ClinicalTrials.gg
WithdrawnNCT04368520Updated Jul 5, 2024

Clinical Trial to Optimise Levels of Vitamin D for Rhinovirus Protection

A Phase 2 interventional study of Vitamin D3 and Vitamin D3 in Common Cold, sponsored by Queen Mary University of London. Withdrawn at 1 site in United Kingdom. Open to participants aged 18 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-07-05.

Sponsored by Queen Mary University of London · Phase 2, Interventional, and Prevention

Why this study was withdrawn
COVID-19 pandemic prevented start-up
Phase
Phase 2
Study type
Interventional
Enrollment
0
Allocation
Randomized
Ages
18 Years to 70 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 20 studies in Common Cold with a site in United Kingdom — none open to participants now, 1 under way, none of them phase 3. Common Cold · United Kingdom.

Enrollment
20th of 20
0 · median 89
Started
2020
the only one that year
Phase 2
4 of 20
none open now
Registered
16th of 20
by date

Among the 20 studies in Common Cold with a site in United Kingdom, this one is the 20th largest by enrollment, is the only one that started in 2020, is one of 4 in phase 2, and was the 16th registered.

Common Cold

219 studies on the registry are indexed under Common Cold; 23 are open to participants now.

Browse Common Cold studies →

Open to participants now

None of the 20 studies in Common Cold with a site in United Kingdom is open now. The open studies under Common Cold, anywhere →

Who these studies take

Of the 14 Common Cold studies recruiting now, 4 (29%) set no upper age limit and 9 (64%) stop at 75 or younger; 4 take children under 18; 7 take healthy volunteers.

This study: 18 Years to 70 Years · all sexes · healthy volunteers too.

The full table on the hub →

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Download CSVNarrow it in search →With an account: the 20 studies in Common Cold with a site in United Kingdom as a file.
02

Study summary

A phase II randomised, placebo-controlled trial to identify the optimal regimen of vitamin D supplementation for rhinovirus protection, determined by host responses to a clinically induced rhinovirus challenge. The primary outcome is rhinovirus titre after inoculation with rhinovirus; secondary outcomes are self-reported respiratory symptom scores, concentrations of cytokines and chemokines sampled from the nasal mucosa, and the transcriptional responses of nasal epithelial cells.

03

Conditions studied

  • Common Cold

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Keywords

  • Rhinovirus
04

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Age 18-70 years
  2. Gives written
  3. Serum 25-hydroxyvitamin D concentration \<75 nmol/L
  4. Agrees not to take supplement containing vitamin D during participation
  5. Agrees not to commence smoking or vaping during participation

Exclusion criteria

Exclusion criteria:

  1. Current smoker or vaper
  2. Taken vitamin D supplement or other supplement containing vitamin D, in previous 3 months
  3. Sunny holiday abroadI, defined as any location 51 degrees North/South of the equator, for ≥1 week, in the previous 3 months
  4. Dependent(s) \<6 months old
  5. Positive serology for anti-RV16 antibodies
  6. Living with someone with severe airways disease
  7. Any of the following medical conditions:

    1. Diabetes mellitus
    2. Asthma
    3. Respiratory allergies
    4. Sarcoidosis
    5. Hyperparathyroidism
    6. Nephrolithiasis
    7. Active tuberculosis
    8. Liver failure
    9. Renal failure
    10. Lymphoma or other not in remission for ≥ 3 years
Terms in these criteria, in plain language(3)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

COPD

Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

05

Study design

Phase
Phase 2
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
0 participants (actual)

Study arms

  • Placebo comparator
    Placebo

    Other: Placebo

  • Experimental
    Low dose vitamin D3

    Dietary Supplement: Vitamin D3

  • Experimental
    High dose vitamin D3

    Dietary Supplement: Vitamin D3

Interventions

  • Dietary supplementVitamin D3

    800 IU Fultium-D3, cholecalciferol (Internis), given daily for 3 months

  • Dietary supplementVitamin D3

    3,200 IU Fultium-D3, cholecalciferol (Internis), given daily for 3 months

  • OtherPlacebo

    Hypromellose capsules, given daily for 3 months

06

What researchers measure

Primary outcomes

  1. Rhinovirus titres

    PCR-detected rhinovirus-16 load sampled from the nasal mucosa

    Time frame: +3 to +5 days after inoculation

Secondary outcomes

  1. Respiratory symptom score (Jackson Score)

    Total self-reported respiratory symptom score (scored 0-32; increasing score equals increasing symptom severity)

    Time frame: +1 to +14 days after inoculation

  2. Cytokine and chemokine concentrations

    Change in concentrations of inflammatory mediators (Including, but not limited to IL-1β, IL-2, IL-4, IL-5, Il-6, IL- 7, IL-8 \[CXCL8\], IL-10, IL-12, IL-13, IL-15, IL-17, IL-1RA, IL-2R, IFN-α, IFN-γ, TNF-α, MCP-1 \[CCL2\], MIP- 1α \[CCL3\], MIP-1β \[CCL4\], RANTES \[CCL5\], eotaxin \[CCL11\], MIG \[CXCL9\], IP-10 \[CXCL10\], EGF, FGF-basic, HGF, VEGF, G-CSF, GM-CSF)

    Time frame: Day 0 and +4 days after inoculation

  3. Change in level of vitamin D-regulated gene expression

    Change in expression of DHCR7, CYP2R1, CYP3A4, CYP27A1, CYP27B1, CYP24A1, VDR, DBP, RXRA

    Time frame: Day 0 and +4 days after inoculation

07

Study locations

1 site
  • St. Mary's Hospital
    London, W2 1NY, United Kingdom
08

References and documents

Individual participant data

Plan to share: Yes — De-identified IPD will be shared with other researchers subject to terms of Data Transfer Agreement and IRB approval

Supporting information: Study protocol, Statistical analysis plan, Analytic code

Time frame: 2 years after completion of the trial

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Start is estimated for Mar 2020; primary completion for May 2022, 26 months later.

How these figures are worked out, and which studies are left out of them.

Registered
Mar 26, 2020
First posted
Apr 29, 2020
StartEst.
Mar 1, 2020
Primary completionEst.
May 1, 2022
CompletionEst.
May 1, 2022
Last update
Jul 5, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jul 5, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04368520
Responsible party
Sponsor
First posted
Apr 29, 2020
Start date
Mar 1, 2020 (estimated)
Primary completion
May 1, 2022 (estimated)
Completion
May 1, 2022 (estimated)
Last update
Jul 5, 2024

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is withdrawn, as verified in Jul 2024. You cannot join it, but the record below documents what was studied.

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Discussion

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Studies of the drug tested here: Cholecalciferol

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